CALGARY, Alberta, Dec. 19, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX)
today announces the independent Data and Safety Monitoring Board (DSMB) has completed an eighth planned safety review for the
Company's Phase 3, BETonMACE trial for high-risk cardiovascular disease (CVD) patients and recommended the study continue without
modification. The DSMB reviewed available safety data and commented that no safety concerns were identified. Resverlogix, the
clinical steering committee, and all investigators remain blinded to the trial data.
"Following review of data from all 2,425 patients in the BETonMACE clinical trial, the DSMB concluded the study
safe and recommended that we continue per protocol. We are now accruing the final events – to yield at least 250 pre-specified MACE
events – prior to study completion," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
BETonMACE
Apabetalone (see description below) is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD
patients with type 2 diabetes mellitus and low levels of high-density lipoprotein. The primary endpoint of the BETonMACE trial is
designed to establish a relative risk reduction of Major Adverse Cardiac Events, narrowly defined as a single composite endpoint of
cardiovascular death, non-fatal myocardial infarction or stroke. In BETonMACE, two additional pre-specified endpoints will be
captured, the first being renal function. Approximately 11% of the participants in the study had Stage 3 chronic kidney disease at
randomization, which is defined by an estimated glomerular filtration rate below 60 and higher than 30 mL/min/1.73 m2.
Additionally, pre-specified analysis of cognitive function will take place in approximately 19% of the study participants aged 70
and older. Cognitive function will be assessed using the Montreal Cognitive Analysis (MoCA). This group will be tested in the
following categories: those with a baseline MoCA of 26 or above, deemed cognitively normal, and those with a baseline MoCA of 25 or
below, defined as those who have some form of cognitive disorder.
The BETonMACE trial is currently expected to be completed within the first half of calendar 2019, with third
party adjudication of all MACE events anticipated to be available within two to three months past trial completion. The topline
results of the study will be made available shortly thereafter.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET
(bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing
genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition
of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk
cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis,
neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described
safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
Follow us on Twitter: @Resverlogix_RVX
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com
This news release may contain certain forward-looking information as defined under applicable Canadian
securities legislation, that are not based on historical fact, including without limitation statements containing the words
"believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar
expressions. In particular, this news release includes forward looking information relating to the Company's Phase 3 clinical trial
and the potential role of apabetalone in the treatment of high-risk cardiovascular disease, diabetes mellitus, chronic kidney
disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and
other orphan diseases. Our actual results, events or developments could be materially different from those expressed or implied by
these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By
their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our
Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at
www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement
and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required
by law, to update or revise any forward-looking statements, whether as a result of new information, future events or
otherwise.
